Enabling Technologies to Accelerate Development of Oral Biodevices (R43/R44 Clinical Trial Not Allowed) | PA 19 076

Opportunity Information: Apply for PA 19 076

The NIH funding opportunity "Enabling Technologies to Accelerate Development of Oral Biodevices (R43/R44 Clinical Trial Not Allowed)" (PA 19-076) is a Small Business Innovation Research/Small Business Technology Transfer-style grant program aimed at pushing intraoral biodevices from promising concepts toward practical clinical use. The main goal is to support transformative engineering work that solves the real technical bottlenecks that keep oral biodevices from being reliably built, optimized, validated, and translated. The focus is not on running clinical trials under this award, but on the enabling technology development that makes later clinical studies and commercialization feasible.

At its core, the FOA is looking for projects that create new biodevices or significantly improve existing ones, with an emphasis on technologies that can operate inside the mouth and produce clinically useful information or therapeutic benefit. The NIH highlights applications aligned with precision medicine, meaning devices that can help detect or diagnose disease earlier, guide individualized treatment decisions, monitor response over time, or capture meaningful measures of function and outcomes. While the mouth is the device environment, the intended impact spans both oral health conditions and systemic disease, recognizing that oral biomarkers and oral-based sensing/therapeutic platforms can be relevant to broader medical care.

A central theme is integration: applicants are encouraged to propose engineering approaches that combine electronic, physical, and biological systems into a functional, safe, and effective intraoral platform. In practice, this can include work on multifunctional biosensors, materials and coatings suitable for the oral cavity, microfabrication approaches, power and communication strategies, biocompatibility and safety engineering, signal processing and analytics, and robust packaging that can survive saliva, mechanical forces, temperature variation, and biofouling. The FOA is essentially asking applicants to bridge the gap between a lab concept and a deployable prototype by addressing the messy, high-risk engineering details that determine whether an intraoral device can be worn or used comfortably and produce accurate, repeatable results.

The expected outputs are tangible proof-of-concept prototypes and the key components needed to make them work. That includes prototype intraoral biodevices, dedicated biosensors designed for specific oral targets, and "core technologies" that can serve as building blocks for future devices. The program also supports integrated approaches, meaning combinations of subsystems (sensor plus materials plus electronics plus data pipeline, for example) that together demonstrate a credible path to a safe and effective product intended for a clearly defined clinical application.

The FOA strongly encourages interdisciplinary collaboration because intraoral biodevices sit at the intersection of multiple technical domains. Competitive projects are expected to draw from engineering and sensor development, but also from areas like pharmacology (for drug delivery or therapeutic functions), chemistry (for assays, biomarker detection, surface chemistry, antifouling strategies), and clinical disciplines such as medicine and dentistry (to ensure the device fits real clinical workflows and addresses meaningful endpoints). The announcement also explicitly encourages partnerships between academia and industry, reflecting an intent to promote translation, manufacturability, and eventual commercialization rather than purely exploratory research.

Eligibility is limited to small businesses, consistent with the R43/R44 mechanism. Foreign institutions and non-U.S. entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, "foreign components" may be allowed in certain cases as defined by NIH policy, which typically means a U.S.-based applicant can sometimes include limited foreign involvement if it is well-justified and compliant with NIH requirements.

Administratively, this is an NIH discretionary grant opportunity in the health category (CFDA 93.121). The original closing date listed for the opportunity was January 5, 2022, and the public synopsis does not specify an award ceiling or the expected number of awards, implying that award size and volume would depend on NIH budgets, application quality, and program priorities. Overall, the opportunity is designed for small businesses with strong engineering and translational plans to develop enabling technologies and prototypes for intraoral biodevices, while stopping short of supporting clinical trial execution under this specific FOA.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Enabling Technologies to Accelerate Development of Oral Biodevices (R43/R44 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121.
• This funding opportunity was created on 2018-11-26.
• Applicants must submit their applications by 2022-01-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PA 19 076

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